Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)

Last updated: December 9, 2022
Sponsor: University of Pennsylvania
Overall Status: Active - Not Recruiting

Phase

3

Condition

Psoriatic Arthritis

Psoriasis And Psoriatic Disorders

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT05631457
851448
  • Ages 18-80
  • All Genders

Study Summary

The trial is a double-blinded randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Psoriatic arthritis meeting CASPAR criteria;
  2. Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints
  3. At least one active psoriasis plaque;
  4. Using a TNFi or previously used a single TNFi historically and either never respondedor lost response (TNF IR) and planning to switch to a new biologic therapy;
  5. If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide,hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeksand remain on a stable dose during the study; Only use of a single OSM/csDMARD isallowed.
  6. If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis,must be on a stable dose for 4 weeks and remain on a stable dose during the study;
  7. age 18-80

Exclusion

Exclusion Criteria:

  1. Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, oran IL23i);
  2. An adverse event that precludes use of another TNFi (development of drug-induced SLE,allergic reaction, serious infection, heart failure symptoms, demyelination at anypoint during use of therapy) or any other contraindication or substantial intoleranceto a TNFi;
  3. Use of moderate to high dose glucocorticoids (>10 mg).
  4. Already meet the primary outcome at screening or baseline
  5. Currently pregnant or actively trying to conceive

Study Design

Total Participants: 300
Study Start date:
February 01, 2023
Estimated Completion Date:
May 31, 2025

Study Description

The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i), is more effective than switching to another TNFi. Switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in the clinical practice setting among patients who are TNF IR.

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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